Effects of Synbiotics on Obesity

Synbiotics are a combination of probiotics and prebiotics that can promote the survival of probiotics in the gut. Probiotics utilize prebiotics to produce various metabolites beneficial to human health, such as short-chain fatty acids. The purpose of this trial is to evaluate the impact of a synbiotics product developed by Leewenhoek Laboratories Co., Ltd., on human obesity and its related biomarkers. Participants will be randomly assigned to either the experimental group or the control group in a double-blind trial. The intervention involves the experimental group taking the synbiotics product twice daily, two capsules per dose, after meals for six weeks. The control group will take an equal amount of placebo daily. During the trial, participants' body weight will be recorded weekly, and their body weight, waist circumference, hip circumference, body fat composition, and skeletal muscle mass will be measured before and after the intervention. Additionally, fasting blood samples and blood samples collected at 30, 60, 90, and 120 minutes after consuming the nutritional supplements will be analyzed. The study will compare body fat percentage, body weight, BMI, waist circumference, hip circumference, skeletal muscle mass, and obesity-related biomarkers in blood between the experimental and control groups. The trial results will be used to assess the efficacy of the synbiotics product in improving obesity and its related biomarkers.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age between 20-60 years.
Body weight ≥ 50 kg.
Body Mass Index (BMI) ≥ 24.
Body fat percentage ≥ 30% for females or ≥ 25% for males.
Waist circumference ≥ 80 cm for females or ≥ 90 cm for males.
No remarkable medical history within the past six months.
Willing to comply with the nutritional instructions during the study period.
Willing to report body weight once a week.
Willing to report dietary and activity records.
Willing to comply with the instruction of "not using" other products containing probiotics or enzymes (excluding yogurt and yogurt drinks).
Willing to sign Clinical Trial Informed Consent Form before the trial.

Exclusion criteria

Pregnant or breastfeeding.
Without statutory notifiable diseases, including HIV, syphilis, hepatitis B, hepatitis C, etc.
Judged by a physician to have "secondary obesity" (obesity caused by endocrine disorders or metabolic abnormalities).
Presence of endocrine disorders, hypertension, diabetes, cerebrovascular diseases, cardiovascular diseases, liver diseases, kidney diseases, gastrointestinal diseases, or mental disorders.
Currently taking medications for lipid-lowering, blood sugar control, or weight loss.
Currently taking antibiotic-related medications.
Determined unsuitable for participation in this trial by a physician.

Treatment and study plan

Placebo

Other

Placebo is administered in capsules (500 mg each). Participants are instructed to take the capsules twice daily, with two capsules per dose, after meals. The duration of the intervention is 6 weeks.

Synbiotics

Other

Synbiotics is administered in capsules (500 mg each). Participants are instructed to take the capsules twice daily, with two capsules per dose, after meals. The duration of the intervention is 6 weeks.

Primary outcomes

Body fat percentage

Time frame: Up to six weeks

The difference in body fat percentage between experimental group and control group.

Study contacts

Contact information is provided by the study sponsor or research team.

Chi-Shan Li, PhD

CONTACT

[email protected]

+886-2-2377-2318 ext. #201

Chiwo-Wei Lin, PhD

CONTACT

[email protected]

+886-2-2377-2318 ext. #201

Sponsors and collaborators

Lead sponsor

Leeuwenhoek Laboratories Co. Ltd.

Industry

Registry information

Official study title

Effects of Synbiotics on Obesity and Obesity-related Parameters

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Aug 29, 2024
Registry last updated: Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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